SECTION I INTRODUCTION TO THE INSTRUMENT

Figure 1.1 the Boehringer Mannheim Diagnostics/Hitachi 704

1.1 INSTRUMENT CHARACTERISTICS

The Boehringer Mannheim Diagnostics/Hitachi 704 (Figure 1.1)

is an automated serum chemistry analyzer. Some of its
characteristics include:

. READY-TO-USE 24 HOURS PER DAY . QC CAPABILITIES FOR SIX (6) CONTROL LEVELS

. USER-FRIENDLY KEYBOARD AND CRT . AUTOMATIC EVALUATION OF WITHIN-RUN CONTROL

RESULTS
. 180 TEST/HOUR THROUGHPUT
. MAY BE INTERF ACED WITH HOST COMPUTER
. MICRO (3-20 MICROLITER) SAMPLE SIZES
. RESULTS STORED ON FLOPPY DISK
. REFRIGERATED STORAGE FOR FORTY (40) REAGENT
CONTAINERS . AUTOMATED MAINTENANCE FUNCTIONS

. ENDPOINT, KINETIC AND ISOENZYME CHEMISTRIES The Instrument is divided into two major operational systems:

. FOUR (4) PARAMETER LOGIT DATA REDUCTION FOR . The Control System is that part of the Instrument with
NONLINEAR CHEMISTRIES which the Operator is actively involved.

. AUTOMATIC SAMPLE BLANKING . The Reaction System is that part of the Instrument which
is directly involved in chemical analysis of patient samples.

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1.2 INSTRUMENT CONTROL SYSTEM QC KEY

The Instrument Control System consists of Instrument
components through which the Operator controls all Instrument
functions. These components include the keyboard, computer,
CRT and printer. An interface port for a host computer is
available for use, if desired.
To view the QC Job Menu, press the QC key. This menu lists
displays where:
. Control data is evaluated by a multi-rule Shewhart type
analysis

1.2.1 INSTRUMENT KEYBOARD AND CRT DISPLAYS . Daily QC data is listed for a specified control

The keyboard (Figure 1.2) is used to both request and address . Daily QC data is graphed for a specified control
CRT displays. Through CRT displays, information is entered
into computer memory and Instrument functions are controlled. . Cumulative QC data is listed for a control

Each CRT display contains information of a specific nature. . Cumulative QC data is graphed for a control
For example, the Chemistry Parameters display contains
information necessary for the Instrument to perform a specific
chemical analysis.

Similar CRT displays are grouped into menus (Job Menus).

For example, displays used regularly during routine patient
processing are grouped together in the Routine Job Menu. To
view the Routine Job Menu, press the ROUTINE key.

In some cases, an individual CRT display may not be listed in

a Job Menu. The STAT display is an example. To view the STAT
Test Selection display, press the STAT key. See “STAT key” on
the following page.

Each key or group of keys is described in the following

paragraphs:

ROUTINE KEY MONITOR KEY

To view the Routine Job Menu, press the ROUTINE key. This To view the Monitor Job Menu, press the MONITOR key.
menu lists displays which allow you to: Displays listed in this menu allow you to:

. Verify remaining reagent volumes . View absorbance changes vs. time for recent reactions

. Request patient testing . Edit and print patient and control files

. Request controls and/or calibration . View calibration data for wet chemistries

. Specify certain conditions of operation . View ISE calibration data

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PARAMETER KEY OPERATION MONITOR

To view the Parameter Job Menu, press the PARAMETER key.
Displays listed in this menu allow you to:
. Define chemistry parameters for each test
. Assign a chemistry to each channel
. Assign short test names
. Define profiles
. Define calculated tests (e.g., A/G ratio)
. Customize patient report format
To view the Operation Monitor display, press the OPERATION
MONITOR key. This display does not permit input, but provides
the following data:
. Analyzer status
. Incubation bath temperature
. Identification of the specimen being sampled
. Chemistry configuration (PHASE) in use
. Current date and time
. Instrument alarms

MAINTENANCE KEY STAT KEY

To view the Maintenance display, press the MAINTENANCE To request STAT patient testing, press the STAT key. This may
key. Functions listed in this display allow you to: be done at any time.

. Perform maintenance functions

. Copy or format floppy disks

. Perform precision checks of the Instrument Diagnose

mechanical malfunctions

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NEXT AND BACK KEYS CONTINUE KEY

NEXT and BACK are used to change the CRT display to a
different display within that same job menu. For example, after
specifying tests to be calibrated on Test Selection (2) (Routine
Job #3), press the NEXT key to view Start Conditions (Routine
Job #4). These keys may also be used to select the first or last
display when the menu is displayed on the CRT.
Sometimes information displayed on the CRT screen is only
part of the information available for that display. To view
remaining data that does not appear on the initial display, press
CONTINUE.
BUZZER OFF KEY

ENTER KEY Press BUZZER OFF once to silence the audible alarm. Pressing
the key a second time will clear alarms listed on the Operation
Press ENTENER after typing information which is to be entered Monitor display.
into an entry field on the display.
NUMERIC KEYPAD
CURSOR CONTROL KEYS

The cursor control keys are used to move the cursor block
from one entry field to another within a display.

To move the cursor block from the first entry field in a display
toward the last, press

To move the cursor block from the last entry field in a display
toward the first, press

The cursor can be made to move backward from the first field
to the last, or from the last field forward to the first.

COPY KEY

Press COPY to print a copy of the display currently shown on The numeric keypad is used for numeric input, as required.
the CRT. The Instrument must be in Standby when the COPY
key is used. PROFILE AND TEST SELECTION KEYS

CLEAR KEY

CLEAR is used to clear one of two types of input errors:

. When incorrect information has been typed, but the

ENTER key has not yet been pressed.

. When incorrect information has been typed, but the

ENTER key has been pressed.

When unacceptable information has been entered, an input

alarm is issued. No other entries will be performed until
c is pressed to clear the input error.
If incorrect information is entered and accepted, it can be
corrected by moving the cursor back to the specified field and
entering the correct information.
The profile/test selection keys may be used in one of two ways:
. As test or profile selection keys, as defined in the Channel
Setting and Profile Definition displays.
. As an alphabetic keyboard, as indicated on each key. Note
that the numbers on each test selection key indicate
channel number only, and are not used for numeric input.

Each key has an indicator light, which is active when the keys
are used as profile or test selection keys.

When one of these keys is pressed, the indicator is illuminated.

When the key is pressed a second time, the light goes out.

When the ENTER key is pressed, any test or profile selection

key with its indicator light ON will be used to assign test
selection.

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STOP KEY
Press STOP to instruct the Instrument to stop test processing
at the end of the current Instrument cycle.
STOP is also used to end test program functions and to
terminate communication with a host computer.
SAMPLING STOP KEY
Press S. STOP to instruct the Instrument to stop sampling at
the end of the current Instrument cycle. When this key is
pressed, only the sampling operation stops. All other functions
related to processing tests continue until results print out.
START KEY
Press START to place the Instrument into the Operate mode.
Always consult the Start Conditions display before pressing
START.
1.2.2 COMPUTER
Computer activity is controlled through the use of the keyboard
and CRT. The Instrument computer controls and monitors all
Instrument functions, calculates results from raw absorbance
data, and stores information on the System and Data Disks.
1.2.3 FLOPPY DISK DRIVES
There are two floppy disk drives positioned below the
Instrument CRT and keyboard (Figure 1.12). The left drive holds
the System Program Disk, and the right drive holds the Data
Disk.
Figure 1.12 Floppy Disk Drives
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When the Instrument ON/OFF switch is turned ON, all
Instrument operating parameters are automatically read from
the System Program disk into computer memory.
The Data Disk records test results for a maximum of 400 routine
samples and 40 stat samples. When this disk becomes full, it
can be removed from the Instrument and saved to maintain a
record of test results. If this type of record is not desired, the
disk can be reformatted (cleared of all data) and reused.
1.2.4 PRINTER
The Instrument uses an 80 column, dot matrix printer (Figure
1.13). Patient results can be printed in 8-1/2 X 11 inch report,
or can be printed in a monitor format, which uses less paper.
Examples of each printed report are found in Section 7,
Reports.
Figure 1.13 Instrument Printer
1.2.5 HOST INTERF ACE
The Instrument can be interfaced with a Host Computer. For
details concerning interfacing capabilities, contact Boehringer
Mannheim Technical Service.
1.3 REACTION SYSTEM
The reaction system includes all Instrument components which
are directly involved in chemical analysis of samples. Major
components of the reaction system, and their involvement in
reaction processing are:
. REACTION DISK: central component of reaction
processing; a motor-driven turntable which holds reaction
cells (cuvettes) at its perimeter.
. SAMPLING SYSTEM: transfers sample from a sample cup
into a reaction cell where the reaction process takes place.
. REAGENT SYSTEM: adds appropriate reagent(s) to a 1.3.2 SAMPLING SYSTEM
sample-containing reaction cell.
SAMPLE DISK
. STIRRING UNIT: stirs the contents of each reaction cell
after the addition of each reagent. The sample disk (Figure 1.14) is a motor-driven turntable, with
three concentric rings of sample cup positions:
. REACTION BATH: positioned directly beneath the
reaction disk. All reaction cells are immersed in this bath, OUTER RING: 40 positions for ROUTINE samples
which maintains the temperature of reaction mixtures at
37 degrees C. If necessary, reaction bath temperature MIDDLE RING: 30 positions for BLANKS and
maybe set at installation to either 25 or 30 degrees C. CALIBRATORS

. PHOTOMETER: reads the absorbances of reaction cell
contents.
. REACTION CELL RINSE UNIT: cleans each reaction cell
after final absorbance reading. Also works with the
photometer to determine blank absorbance of each
reaction cell before use.
Each of these components are discussed in greater detail in
the paragraphs that follow.
1.3.1 REACTION DISK
The Reaction Disk (Figure 1.14) is a motor-driven turntable. It
holds forty-eight (48) reusable plastic reaction cells (cuvettes)
at its perimeter. All chemical analyses take place in these
reaction cells. The reaction cells are immersed in a circular
Reaction Bath, which is positioned beneath the Reaction Disk.
INNER RING: 10 positions for STAT samples 6 positions
for CONTROLS 1 position for WASH
solution 3 positions for ISE calibrators
Blank, calibrator and control materials are placed in dedicated
positions on the disk.
Routine and stat patient samples are placed in positions that
are defined when selecting tests to be run.
When the Instrument is ready to sample a specimen, the sample
disk rotates, bringing the desired sample cup into position next
to the sample probe (sampling station).
The sample disk has a locking cover which helps to prevent
sample evaporation. The cover has three holes through which
sampling can occur while the cover is in place.

The Reaction Disk is surrounded by Instrument components

that are involved in the reaction process: Sampling System,
Reagent Dispense System, Stirring Unit, Photometer and Cell
Rinse Unit.

Figure 1.14 Reaction Disk and Associated Systems

SAMPLE PROBE SAMPLE PIPETTOR

The sample probe (Figure 1.15) carries sample from a sample
cup to a reaction cell. The probe is attached to the sample
(serum) pipettor, and has a liquid level sensor wire at its tip.
The liquid level sensor informs the Instrument Computer when
the tip of the sample probe is immersed in sample. The sample
probe is mounted on the sample probe arm.
The sample pipettor (Figure 1.16) is a positivedisplacement
pipettor, positioned behind the left side cover of the Instrument.
The pipettor, and the plastic tubing that connects it to the
sample probe, are filled with deionized water.
When the Instrument is prepared to aspirate sample, (sample
probe tip is in sample), the pipettor motor withdraws the plunger
from the chamber of the pipettor, and sample is aspirated into
the tip of the sample probe.

Once the sample probe has been lowered into the reaction
cell, the pipettor motor is reversed, and sample is dispensed.

Figure 1.15 Sample Probe and Arm

SAMPLE PROBE ARM

When a sample cup has been brought into position for

sampling, the motor-driven sample arm (Figure 1.15) moves
the sample probe from its reset (home) position to the sample
disk, then lowers it into the sample cup. Once the sample probe
liquid level sensor detects sample, the sample probe arm stops,
and sample is aspirated.
Figure 1.16 Sample Pipettor
After sample has been aspirated, the probe is lifted from the
sample cup and moved to the reaction disk. The sample probe SAMPLE PROBE RINSE STATION
arm lowers the probe into the reaction cell at the sample
dispense position, and stops when the probe touches the The sample probe is at its home position when it is directly
bottom of the cell. Sample is dispensed while the sample probe above the sample probe rinse station (Fiugre 1.15), between
tip is in contact with the bottom of the reaction cell. This ensures the sample disk and reaction disk. When the Instrument finishes
that a precise volume of sample is deposited into the cell, and sampling a specimen, the sample probe is lowered into its
is necessary due to the small dispense volume. The sample rinse station. While in the rinse station, water is jetted through
probe is spring-mounted on its arm to avoid damage to the the probe and onto the surface of the probe tip. This rinse
probe or reaction cell. removes any serum adhering to the inside or outside of the
probe.
Following sample dispense, the sample probe arm lifts the
sample probe from the reaction cell and moves it to the sample
probe rinse station.

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1.3.3 REAGENT SYSTEM
REAGENT DISK
Reagent containers are stored on the Instrument in a reagent
disk (Figure 1.17). The reagent disk is held within a refrigerated
compartment. The top surface of the disk has positions for a
maximum of forty reagent containers. This allows a maximum
of two reagents for each of twenty chemistry channels. When
reagent containers are placed into the disk, they are contained
within the refrigerated chamber of the disk.
When the Instrument is ready to add a reagent to a reaction
cell, the reagent disk rotates, bringing the appropriate reagent
container into position next to the reagent probe (reagent
aspiration station).
The reagent disk has a locking cover which helps prevent
evaporation of reagents. The cover has an opening through
which the Instrument can aspirate reagent.
REAGENT PROBE ARM
When a reagent container has been brought into position at
the reagent aspiration station, the reagent probe arm (Figure
1.18) moves the reagent probe from its home position to the
reagent disk, and lowers the probe into the reagent container.
Once the reagent probe liquid level sensor detects reagent,
the Instrument stops lowering the probe, and reagent is
aspirated.
After reagent has been aspirated, the probe is lifted from the
reagent container and carried to the reaction disk, where
reagent is dispensed. Unlike the sample probe, the reagent
probe is not lowered into the reaction cell.
Following reagent dispense, the reagent probe is moved to
the reagent probe rinse station.

Figure 1.17 Reagent Disk Figure 1.18 Reagent Probe and Arm

REAGENT PROBE

The reagent probe (Figure 1.18) carries reagent from the reagent
disk to the reaction disk. It is attached to the reagent pipettor,
and has a liquid level sensor wire at its tip. The liquid level
sensor informs the Instrument when the reagent probe tip is
immersed in reagent, and is used to calculate approximate
number of tests remaining from a reagent container. The reagent
probe can add a second reagent to the reaction cell five minutes
after the addition of the first.

The reagent probe is mounted on the reagent probe arm.

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REAGENT PIPETTOR
The reagent pipettor (Figure 1.19) is a positive displacement
pipettor, positioned behind the left side cover of the Instrument.
The pipettor, and the plastic tubing which connects it to the
reagent probe, are filled with deionized water. The reagent
system does not require priming with reagent.
When the reagent probe tip is immersed in reagent, the reagent
pipettor motor withdraws the plunger from the chamber of the
pipettor, and reagent is aspirated into the reagent probe.
Once the reagent probe is in position above the stationary
reaction disk, the pipettor motor is reversed, and reagent is
dispensed into the reaction cell.
Figure 1.19 Reagent Pipettor
REAGENT PROBE RINSE STATION
The reagent probe is at its home (reset) position when it is
directly above the reagent probe rinse station (Figure 1.20),
between the reaction disk and the reagent disk. After each
reagent dispense, the probe is lowered into its rinse station,
where water is jetted through the probe and onto its outside
surface. This rinse removes any reagent adhering to the inside
or outside of the probe.
1.3.4 REACTION MIXTURE STIRRING SYSTEM
STIRRING UNIT
The stirring unit (Figure 1.20) consists of a slender stirring
paddle, the motor that spins the paddle, and the mechanism
that moves the stirring paddle to and from the reaction disk.
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Forty seconds after the addition of each reagent to a reaction
cell, the reaction disk pauses with that reaction cell in position
next to the stirring unit. The stirring unit moves from its home
position to the reaction disk, and the stirring paddle is lowered
into the reaction cell. Once the paddle is fully lowered into the
cell, the stirring motor is briefly activated to mix the contents
of the reaction cell. The stirring unit is then turned off, lifted
from the reaction cell, and returned to its home position.
Figure 1.20 Reagent Probe, Stirring Unit
STIRRING PADDLE RINSE BATH
The stirring unit is at its home position when the stirring paddle
is directly above its rinse bath (Figure 1.20), next to the reaction
disk. After each stirring action, the stirring paddle is lowered
into its rinse station, where it is thoroughly rinsed with deionized
water before being used again.
1.3.5 REACTION BATH
The reaction cells are partially immersed in a temperature-
controlled waterbath (Reaction Bath, Figure 1.21). The ring-
shaped reaction bath is positioned beneath the reaction disk.
Two glass windows (inner and outer) are positioned in opposite
walls on one side of the reaction bath. These windows permit
light from the photometer lamp to pass through the reaction
bath water, and through the reaction cells in the bath. The light
beam emerges from the outer window of the reaction bath
and enters the Instrument photometer.
A small amount of deionized water is automatically added to
the reaction bath every 20 minutes to compensate for
evaporation. In addition, the entire reaction bath water volume
is automatically replaced with fresh deionized water each time
the Instrument is powered up. A detergent (Extran) is
automatically added to the bath whenever the water is
exchanged. Extran prevents microbial growth and prevents air
bubbles from interfering with absorbance readings.
1.3.6 PHOTOMETER 1.3.7 REACTION CELL RINSE UNIT

The photometer is positoned so that absorbance readings of
each reaction cell are taken as the reaction disk is turning.
This arrangement enables the Instrument to read the
absorbance of each reaction cell as frequently as once every
20 seconds.
The reaction cell rinse unit (Figure 1.22) consists of a series of
probes mounted above one side of the reaction disk. The
probes are connected to vacuum lines and deionized water
supply lines. The reaction cell rinse unit performs the following
functions:

The photometer lamp is positioned beneath the center of the
reaction disk, within the ring of the reaction bath. The lamp is
encased in a constant-temperature water jacket (Figure 1.21),
which helps to maintain a constant energy output from the
lamp.
. Removes reaction mixture waste from reaction cells
. Rinses reaction cells with Dl water
. Aspirates rinse water from reaction cells

The light from the photometer lamp passes through the . Dispenses deionized water into reaction cells for
following structures in sequence: photometric cell blanking

1. Inner reaction bath window . Aspirates water from cells after photometric cell
2. Reaction bath water blanking
3. Reaction cell and its contents
4. Reaction bath water . Dries inside walls of reaction cells
5. Outer reaction bath window
6. Photometer These functions occur as part of the routine operation of the
Instrument. Each reaction cell is photometrically blanked with
When the light beam enters the photometer, it strikes a water before sample is dispensed into it, and each cell is
diffraction grating, which separates the light into its constituent thoroughly cleaned after final absorbance measurement of a
wavelengths, and reflects them onto a fixed array of eleven (II) reaction mixture.
photodetectors. Each photodetector is permanently positioned
to detect light at a different wavelength. The reaction cell rinse unit uses the deionized water supply,
and the internal vacuum system.
Absorbance readout information for each chemical analysis is
programmed into the Instrument computer. The computer
selects the wavelengths and the times at which a reaction
mixture’s absorbance is read.

The Instrument computer keeps track of which test is being

performed in each reaction cell. It also knows when each
reaction cell passes through the photometer light path. The
computer uses this tracking ability and the programmed
readout instructions to obtain test results. A complete
discussion of the Instrument’s calculation of results is found in
Section 3 of this manual.

Figure 1.21 Reaction Bath and Photometer Lamp Figure 1.22 Reaction Cell Rinse Unit

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DEIONIZED WATER SUPPLY SYSTEM
The deionized water supply system consists of the deionized
water reservoir (Figure 1.23) and a series of pumps and
electronic valves. Water is supplied to the reaction cell rinse
unit directly from the deionized water reservoir. If your
Instrument is connected to an external water source, the
reservoir water level is monitored. Water is automatically added
to the reservoir, when necessary.
Water from this source is also supplied to the probe and stirring
unit rinse baths, and to the reaction bath.
VACUUM SYSTEM
The vacuum system consists of a vacuum pump, vacuum
reservoir, and serum waste container (Figure 1.23). The vacuum
system is used by the reaction cell rinse unit to aspirate reaction
mixture waste and reaction cell rinse water. Reaction mixture
waste drains into the reaction waste container. Reaction cell
rinse water leaves the Instrument through the main drain line.
Figure 1.23 Water Compartment
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1.3.8 ION SELECTIVE ELECTRODES (ISE)
The ISE system provides the instrument with an electronic
method for assay of sodium, potassium and chloride on a single
patient serum sample. The ISE unit consists of three ion
selective electrodes, a reference electrode, a dilution vessel
and three pipettors. ISE reagents are stored in the door of the
water compartment.
When electrolytes are requested, sample (20 µl) is aspirated
by the sample probe, and the probe moves to the ISE dilution
vessel. The dilution vessel is protected by a mechanical shutter
that opens when the probe is in position to dispense sample.
Sample and ISE diluent are simultaneously pipetted into the
ISE dilution vessel. The diluted sample is transported through
the ISE measuring cartridges by a “sipper” pipettor, and voltage
readings are obtained for each electrolyte.
The electrical potential generated by sodium, potassium and
chloride is compared with the electrical potential generated at
the reference electrode. Electrical information is sent to the
instrument computer for results calculation.
If electrolytes are assayed in the ISE STAT mode, 60 samples
can be processed every hour. When electrolytes are assayed
together with wet chemistries, ISE throughput is dependent
upon the number of wet chemistries requested for each
specimen.